Quality Assurance Specialist
Current• Review and approvals of Change controls, Deviations, CAPA, Quality Risk assessment and Drug Product Complaints.• Review and approval of QAMS trends (Change controls, deviations, CAPA and Quality Risk assessment).• Preparation and review of Gap assessment reports for regulatory guidelines and inter units audit observations.• Investigation of Drug Product Complaints, Deviations and non-conforming product and proposing the appropriate CAPA’s.• Scheduling and executing self-inspection plan and taking part in Customer / Regulatory inspections.• Preparation and review of audit compliance report to the internal and external audits• Preparation and review of Batch manufacturing records, Batch Packaging records.• Preparation and review of Site Master File, Quality Manual, Quality Assurance and other departmental SOP and implementation of respective procedures. • Sampling of raw materials, packaging materials, in-process samples and finished product samples.• Sampling of Cleaning validation samples, in process samples, finished product and submission to QC for testing.• Review and approval of equipment qualification protocols (DQ / IQ / OQ / PQ). • Qualification of vendors for Raw materials.• Preparation and review of Process Validation, Cleaning Validation and Hold time study protocols and reports.• Preparation and Review of APQR and its quality trends.• Conducting and co-ordination of cGMP training for all employees on annual basis and updating the respective employees training documents.• Review of Analytical validation protocols and reports.• Review of analytical validation data against the chromatograms and analytical notebook.• Preparation and review of stability compilation data and stability reports for exhibit and Validation batches.• Maintenance of documentation cell and issuance / retrieval of documents from the other departments.
